Job Description

We are seeking an experienced Design Quality Engineer (DQE) with a strong background in FDA-regulated Medical Device environments. The ideal candidate will be responsible for ensuring products are designed and developed in compliance with regulatory standards, quality requirements, and customer expectations. This role will collaborate closely with R&D, Manufacturing, Regulatory, and Supplier teams to embed quality throughout the product development lifecycle.

Design Control & Product Development

• Ensure compliance with Design Control requirements throughout the product lifecycle in accordance with FDA and ISO standards
• Participate in design planning, cross-functional design reviews, and verification/validation activities
• Review and approve design inputs, outputs, and technical documentation
• Support creation and maintenance of traceability documentation including DHF, DMR, and DHR
• Review and approve Engineering Change Requests (ECRs) and Engineering Change Orders (ECOs)
• Ensure proper change control processes are followed for all design changes
• Support Design Transfer activities to manufacturing and ensure process readiness
• Validate critical design inputs including usability, reliability, manufacturability, performance, and product safety
• Collaborate with internal and external stakeholders to ensure alignment with quality and regulatory requirements

Risk Management

• Facilitate Design and Process FMEA activities and hazard analysis
• Ensure risk controls are identified, implemented, verified, and documented
• Support comprehensive risk management activities throughout the product lifecycle

Quality Management System (QMS) Support

• Support quality audits and inspection readiness activities
• Manage CAPA activities including root cause analysis and corrective/preventive actions
• Contribute to the development and continuous improvement of QMS processes and procedures

• Bachelor s Degree in Engineering, Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management, or related field
• Minimum 5+ years of experience in FDA-regulated Medical Device environments
• Strong experience in Design Assurance, Design Control, and Risk Management
• Hands-on experience with Change Management and Manufacturing Transfer processes
• Strong understanding of medical device regulations and standards including: 21 CFR Part 820 ISO 13485 ISO 14971 EU MDR Medical Device Directives and related global regulations

• Design Quality & Reliability Engineering
• Risk Management & FMEA
• CAPA & Root Cause Analysis
• Design Verification & Validation (V&V)
• Product Traceability & Documentation
• Change Control Management
• Manufacturing Transfer
• Quality Management Systems (QMS)
• Regulatory Compliance
• Cross-functional Collaboration

For applications and inquiries, contact: hirings@openkyber.com

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